Celgene Senior Manager, REMS Advisor-Prescriber & Patient Focus in Summit, New Jersey


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

This position is responsible for providing consulting support to our certified REMS prescribers, understanding and improving the patient experience, partnering with the Celgene Hematology Oncology Consultants, collaboratively managing the development and oversight of REMS materials and training internal and external customers as needed.

Responsibilities include, but are not limited to the following:

  1. REMS Consulting
  • Maintain a thorough understanding of FDA REMS regulations, and industry trends regarding the implementation of REMS

  • Ensure a comprehensive knowledge of REMS department operations, including all SOPs, work practices and systems

  • Assist certified prescribers and internal Celgene partners external to U.S. REMS with any questions, requests or training needs they may have involving any aspect of our REMS programs

  • Obtain a deep understanding of REMS prescriber operating environments through vendor and consulting interactions, stakeholder discussions, conference attendance, Celgene events etc.

  • Analyze REMS prescriber operations and interactions and identify process improvements that could be introduced to reduce REMS administrative burden

  • Represent the REMS department at relevant Celgene meetings as our subject matter expert to educate, inform and engage with cross-functional partners

  • Maintain reports regarding activities, outcomes, and trends

  • Provide best practices and implementation insights to help improve U.S. REMS design

2. REMS Customer Insights:

  • Actively seek direct prescriber and patient feedback about our REMS programs, materials, and supporting environment and additional similar indirect insights from relevant internal functions (e.g. Patient Advocacy, Hematology Oncology Consultants, Sales Training, Marketing, etc.…)

  • Manage the development, maintenance, production, distribution, and reporting of all U.S. REMS prescriber and patient facing materials

  • Conduct quarterly REMS review meetings with Associate Director, REMS Advisor to provide insights about REMS activities, customer experiences, and highlight improvement opportunities

  • Identify technology enhancements that would reduce REMS administrative burden for prescribers and improve customer experience for patients and provide to the REMS Technology team for consideration

  • Participate in REMS technology projects that impact prescribers and patients to ensure they meet customer expectations and provide timely feedback, updates, and release notifications to our external and internal stakeholders

  • Deliver REMS best practices and operational excellence ideas to the Commercial Sales Force to improve stakeholder efficiencies

  • Obtain insights from prescribers and patients on Celgene’s internal REMS operations and provide to Senior Director of Celgene Customer Care Center

  • Analyze prescriber and patient complaints and propose solutions to management

  • Maintain reports regarding activities, outcomes, and trends

3. REMS Training:

  • Train internal non-U.S. REMS personnel on updates regarding REMS technology, materials and process

  • Develop a strategy to ensure training occurs and is implemented for prescribers and patients located on U.S. military bases outside the U.S.

  • Partner with the Commercial Sales Organization to develop a comprehensive REMS training program that ensures the Sales Force understand their role in the REMS programs and develop tools to reinforce and track training in the field

  • Manage the successful delivery of innovative training programs, analyze training outcomes to assess instructor and attendee feedback, and seek continuous improvement

  • Assist Hematology Oncology Consultants with prescriber training and maintain reports regarding activities, outcomes, and trends

4. REMS Strategy:

  • Partner with U.S. REMS Strategy and Policy on REMS publications, abstracts and manuscripts, and present material at conferences when required

  • Assist with internal audits and external inspections to ensure that U.S. REMS is in compliance with FDA regulations

  • Ensure that the prescriber and patient perspectives are incorporated in Celgene’s participation in FDA’s REMS Integration Initiative

5. Additional Tasks:

  • Create REMS Advisory Panel with Hematology Oncology Consultants and facilitate quarterly meetings. Create slides and deliver findings to Associate Director, REMS Advisor

  • Provide scheduled and ad-hoc reports to the leadership team as required

  • Other responsibilities as assigned



Skills/Knowledge Required:

  • At least 7 years’ pharmaceutical experience required with 5 years as a Manager and experience in delivering training preferred, BS/BA degree required, understanding of FDA REMS regulations a plus.

  • Creative thinker and engaging public speaker

  • Strong strategic orientation with ability to translate into operational priorities and plans

  • Exceptional listening and analytical skills, along with excellent written, verbal and interpersonal communication skills

  • Strong willingness to collaborate with internal and external stakeholders

  • Consideration of prescriber office policies regarding visitors a must

  • Confidentiality and integrity are required

  • Advanced user of Excel and Power Point

  • Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities

  • Up to 50% travel required or more

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S

Senior Manager, REMS Advisor-Prescriber & Patient Focus

Location: Summit, NJ, US

Job ID: 17001461